Essentiale forte N capsules 300mg, 180pcs

Composition

>In 1 capsule contains: Active ingredient: soy bean phospholipids containing 76% (3-sn-phosphatidyl) — choline (synonyms: EPL, essential phospholipids) – 300 mg;auxiliary ingredients: solid fat-57,000 mg, soybean oil-36,000 mg, hydrogenated castor oil-1,600 mg, ethanol 96% – 8,100 mg, ethyl vanillin-1,500 mg,4-methoxyacetophenone-0,800 mg, alpha-tocopherol-0.750 mg. Capsule composition:  gelatin-67.945 mg, purified water-11.495 mg, titanium dioxide (E 171) – 0.830 mg, iron oxide yellow dye (E 172) – 2.075 mg, iron oxide black dye (E 172) — 0.332 mg, iron oxide red dye (E 172) — 0.198 mg, sodium lauryl sulfate-0.125 mg.

Pharmacological action

Essential phospholipids are the main elements of the structure of the cell envelope and cellular organelles. In liver diseases, there is always damage to the membranes of liver cells and their organelles, which leads to violations of the activity of related enzymes and receptor systems, deterioration of the functional activity of liver cells and a decrease in the ability to regenerate. The phospholipids that make up Essentiale Forte H correspond in their chemical structure to endogenous phospholipids, but are superior in activity to endogenous phospholipids due to their higher content of polyunsaturated (essential) fatty acids. The incorporation of these high-energy molecules into damaged areas of the cell membranes of hepatocytes restores the integrity of liver cells and promotes their regeneration. Cis-double bonds of their polyunsaturated fatty acids prevent the parallel arrangement of hydrocarbon chains in the phospholipids of cell membranes, the phospholipid structure of the cell membranes of hepatocytes “loosens”, which leads to an increase in their fluidity and elasticity, improves metabolism. The resulting functional blocks increase the activity of enzymes fixed on the membranes and contribute to the normal, physiological pathway of the most important metabolic processes. The phospholipids that make up Essentiale forte regulate lipoprotein metabolism, transferring neutral fats and cholesterol to the oxidation sites, mainly due to an increase in the ability of high-density lipoproteins to bind to cholesterol. Thus, it has a normalizing effect on the metabolism of lipids and proteins; on the detoxification function of the liver; on the restoration and preservation of the cellular structure of the liver and phospholipid-dependent enzyme systems; which ultimately prevents the formation of connective tissue in the liver and promotes the natural restoration of liver cells. When phospholipids are excreted in the bile, the lithogenic index decreases and the bile stabilizes. Pharmacokinetic Smore than 90% of oral phospholipids are absorbed in the small intestine. Most of them are broken down by phospholipase And up to 1-acyl-lysophosphatidylcholine,50% of which immediately undergoes reverse acetylation to polyunsaturated phosphatidylcholine during the absorption process in the intestinal mucosa. This polyunsaturated phosphatidylcholine enters the bloodstream with the flow of lymph and from there, mainly in the form associated with high-density lipoproteins, enters the liver. Pharmacokinetic studies in humans were performed using dilinoleylphosphatidylcholine with a radioactive label (3H and 14C). The choline portion was labeled 3H, and the linoleic acid residue was labeled 14C. The maximum concentration of 3H is reached 6-24 hours after use and is 19.9% of the prescribed dose. The elimination half-life of the choline component is 66 hours. The maximum concentration of 14C is reached 4-12 hours after use and is up to 27.9% of the prescribed dose. The half-life of this component is 32 hours. In the feces,2% of the administered dose of 3H and 4.5% of the administered dose of 14C are detected, in the urine-6% of 3H and only a minimal amount of 14C. Both isotopes are more than 90% absorbed in the intestine.

Indications

• Chronic hepatitis, cirrhosis of the liver, fatty liver of various etiologies, toxic liver damage, alcoholic hepatitis, liver function disorders in other somatic diseases.
• Toxicosis of pregnancy.
• Prevention of recurrent gallstone formation.
• Psoriasis (as an adjunct therapy).
• Traditional syndrome.

Contraindications

Hypersensitivity to phosphatidylcholine, soy, soybeans or other ingredients of the drug. Children under 12 years of age (lack of sufficient evidence base).

Side effects

Essentiale forte H is usually well-tolerated by patients. According to the World Health Organization (WHO), side effects are classified according to their frequency as follows: very common (≥ 1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (From the gastrointestinal tract, the frequency is unknown: stomach discomfort, soft stools or diarrhea. Skin and subcutaneous tissue disorders: Frequency unknown: allergic reactions (rash, exanthema, urticaria), pruritus.

Interaction

Interaction of Essentiale forte H with anticoagulants cannot be excluded. It is necessary to adjust the dose of anticoagulants when co-administered with Essentiale forte N.

How to take, course of use and dosage

Inside. Capsules should be swallowed whole, washed down with a sufficient amount of water (approximately 1 cup). For adolescents over 12 years of age and weighing more than 43 kg, as well as for adults Essentiale ® forte It is recommended to take 2 capsules-3 times a day with meals. As a rule, the duration of application is not limited.

Overdose

The use of Essentiale forte H in doses higher than recommended may lead to increased side effects.

Special instructions

Essentiale forte H can cause severe allergic reactions, as it contains soy bean oil. Patients should be informed that they are taking Essentiale forte. This does not replace the need to avoid the damaging effects of certain substances on the liver (for example, alcohol). Maintenance therapy with phospholipids is justified only if the subjective signs of the condition improve during treatment. Patients should be advised to consult a doctor if symptoms worsen or other unclear symptoms appear.

Storage conditions

Store at a temperature not exceeding 21 °C. Keep out of reach of children.

Active ingredient

Phospholipids

Dosage form

Capsules